Point of View

DTC Campaigns Mislead Public

Are Advertisements for Genetic Tests a Wolf in Sheep’s Clothing?

In September, Myriad Genetics Laboratories launched a direct to consumer (DTC) campaign aggressively advertising its BRACAnalysis testing. The company holds an exclusive patent on genetic testing for the BRCA1 and BRCA2 genes for hereditary breast and ovarian cancer. The advertising campaign renewed the debate over the appropriateness of DTC advertising of genetic testing in general as well as sparked discussion over Myriad’s ads in particular.

The concerns about DTC marketing of genetic tests go beyond general concerns about similar ad strategies for healthcare products such as prescription medications due to the complexity of genetic testing, limited knowledge of genetics among the general public and healthcare providers, and the lack of regulation for these commercials.

Myriad’s DTC marketing campaign includes television, radio, and print ads running in New York, Connecticut, Massachusetts, and Rhode Island that are designed to reach women in their 20s to 50s. These ads encourage women with a family history of breast cancer to speak to their healthcare provider about genetic testing and/or call the company directly for more information.

The first phase of this campaign in January involved marketing to primary care providers through direct-mail flyers and advertisements in professional journals. This part of the campaign is aimed at encouraging these providers to order their own testing directly.

The So-called Public Awareness Campaign

Representatives from Myriad state that this is a public awareness campaign designed to save lives. Some agree that DTC advertising may increase knowledge and encourage patients with a family history to speak to their physicians.

Many experts fear, however, that the risks of DTC marketing of BRCA testing outweigh these stated benefits. They argue that the content of these particular ads is misleading and that even the labeling of Myriad’s marketing as a public awareness campaign rather than a paid advertisement is deceptive.

These advertisements imply that almost all women who have or had a family member with breast cancer are good candidates for this testing. They fail to mention that the vast majority of breast cancer is not hereditary. They do not state the risk factors that can help determine who is an appropriate candidate for genetic testing like early onset of cancer and a combination of breast and ovarian cancer in a family.

Therefore, at the very least, these ads are creating unnecessary anxiety among individuals who are mainly at low risk. They use themes of hope, control, and choice to prey upon our society’s already exaggerated fears of breast cancer and limited understanding of genetic susceptibility and risk.

These ads also exaggerate and oversimplify the benefits of testing. For example, the ad makes statements like “Be ready against cancer” and “Reduce my cancer risk now.” They imply that breast cancer can be avoided via a simple blood test by saying, “I wondered if it would be inevitable; I found out it didn’t have to be.”

These advertisements make no mention of the possible risks of this testing, including complex and uncertain test results, emotional/psychosocial concerns, and discrimination.

The ads only vaguely refer to the effective medical options that are available “to help reduce cancer risk now” for women who are found to carry a BRCA mutation. They do not point out, however, that the most effective options include major surgeries like preventative removal of breasts and/or ovaries with associated risks and emotional and physical side effects.

Proponents of DTC advertising of BRCA testing argue that for some individuals the risks of unnecessary anxiety or even unnecessary testing, albeit expensive at about $3,100, are outweighed by the benefits of increased awareness and having more women pursue this potentially life-saving test.

A Lack of Proper Counseling

There are, however, less obvious but even bigger dangers that may result from this DTC marketing campaign. A major concern among cancer genetics experts is that women may have their test results misinterpreted, which has already been shown to occur frequently. This could lead to unnecessary prophylactic surgery or false reassurance about their risks to develop cancer and a resultant lack of screening that could save their lives.

This danger stems from a clear conflict of interest. Sales representatives sell primary care physicians on ordering their own testing after only a few hours of training and educational materials provided by the testing company. Unfortunately, well-meaning healthcare providers may be unknowingly taking on a huge liability as they sign off on each test request indicating that they have adequately informed their patient and are ultimately solely responsible for the case.

Materials advertising this test to providers imply that genetic counseling and testing for BRCA1 and BRCA2 mutations is a simple process that any provider can offer with help from the company. In fact, representatives from the firm suggest that many physicians can directly discuss results with their patients and only a select group of people with more complex family histories should be referred to genetic counselors.

This statement is in stark contrast to numerous regional, national, and international studies demonstrating that nongeneticist healthcare providers have inadequate knowledge of the essential clinical genetics concepts. Such an understanding is necessary to provide adequate counseling and interpret results. There is also data to suggest that many providers do not routinely collect a sufficiently detailed and extensive family history to accurately assess risk and interpret test results.

A very similar pilot campaign, which was run by Myriad in Atlanta and Denver in 2002, met with strong criticism. There were numerous unfavorable articles, editorials, and news stories. Outcome studies from this campaign showed that it did not meet its stated educational goals; there was no evidence of an increase in knowledge among providers or consumers in the pilot cities. Providers in both the pilot and comparison cities still lacked the necessary understanding to counsel their patients about BRCA testing.

One outcome that is of particular concern is that these providers who were shown to be incapable of appropriate counseling reported an increase in the number of BRCA tests ordered directly. Yet, there was no increase in the number of referrals to genetic counseling centers.

Although the campaign did increase the demand for genetic counseling and testing among high-risk women, it also increased the demand for genetic counseling among many low-risk women as the proportion of referrals of high-risk individuals declined during the campaign.

Myriad’s current DTC campaign has raised concern among healthcare providers and captured the attention of Richard Blumenthal, attorney general of Connecticut, who has issued a subpoena for information from Myriad to determine whether or not the claims in its advertisements are fair and accurate. He has indicated that both the tone and the content of the commercials are troubling.

In the absence of better regulation, industry leaders, healthcare providers, and professional organizations should collaborate to set and adhere to standards for socially responsible genetic testing and marketing of genetic testing to minimize the risks and maximize the benefits for all parties involved.

Click Image To Enlarge +

Karina L. Brierley

Click Image To Enlarge +

Ellen T. Matloff

Karina L. Brierley (karina.brierley@yale.edu) is a genetic counselor at the Yale Cancer Center, and Ellen T. Matloff (ellen.matloff@yale.edu) is a research scientist in the department of genetics at Yale School of Medicine and the director of cancer genetic counseling at Yale Cancer Center. For more information go to www.responsiblegenetictesting.org.

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.

If you have any questions about your subscription, click
hereto email us or call at (914) 740-2189.

You may also be interested in subscribing to the GEN magazine, an indispensable
resource for everyone involved in the business of translating discoveries at the
bench into solutions that fight disease and improve health, agriculture, and the
environment. Subscribe
today to see why over 60,000 biotech professionals read GEN to
keep current in the areas of genomics, proteomics, drug discovery, biomarker discovery,
bioprocessing, molecular diagnostics, collaborations, biotech business trends, and
more.